Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial
Summary Background After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compa...
Gespeichert in:
Veröffentlicht in: | The Lancet (British edition) 2010-07, Vol.376 (9735), p.91-102 |
---|---|
Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , |
Format: | Artikel |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
container_end_page | 102 |
---|---|
container_issue | 9735 |
container_start_page | 91 |
container_title | The Lancet (British edition) |
container_volume | 376 |
creator | Vaidya, Jayant S, Dr Joseph, David J, MD Tobias, Jeffrey S, FRCR Bulsara, Max, PhD Wenz, Frederik, MD Saunders, Christobel, FRCS Alvarado, Michael, MD Flyger, Henrik L, MD Massarut, Samuele, MD Eiermann, Wolfgang, MD Keshtgar, Mohammed, PhD Dewar, John, FRCR Kraus-Tiefenbacher, Uta, MD Sütterlin, Marc, MD Esserman, Laura, MD Holtveg, Helle MR, MD Roncadin, Mario, MD Pigorsch, Steffi, MD Metaxas, Marinos, PhD Falzon, Mary, FRCPath Matthews, April, BSc Corica, Tammy, PGDPH Williams, Norman R, PhD Baum, Michael, FRCS |
description | Summary Background After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy. Methods Having safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam, we launched the TARGIT-A trial on March 24, 2000. In this prospective, randomised, non-inferiority trial, women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries. Patients were randomly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy. Neither patients nor investigators or their teams were masked to treatment assignment. Postoperative discovery of predefined factors (eg, lobular carcinoma) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy (in an expected 15% of patients). The primary outcome was local recurrence in the conserved breast. The predefined non-inferiority margin was an absolute difference of 2·5% in the primary endpoint. All randomised patients were included in the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov , number NCT00983684. Findings 1113 patients were randomly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy. Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group, 854 (86%) received targeted intraoperative radiotherapy only and 142 (14%) received targeted intraoperative radiotherapy plus external beam radiotherapy. 1025 (92%) patients in the external beam radiotherapy group received the allocated treatment. At 4 years, there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group. The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1·20% (95% CI 0·53–2·71) in the targeted intraoperative radiotherapy and 0·95% (0·39–2·31) in the external beam radiotherapy group (difference between groups 0·25%, |
doi_str_mv | 10.1016/S0140-6736(10)60837-9 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_926896736</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0140673610608379</els_id><sourcerecordid>2079967331</sourcerecordid><originalsourceid>FETCH-LOGICAL-c607t-f6c5dbd87d7d66651cef0cab1cda47df651d369d55f5ab0288074335560b57633</originalsourceid><addsrcrecordid>eNqFkVFv0zAUhSMEYmPwE0AW0sQmNXAdx3bCA6iaYEyahARF4s1y7RvqkcbBTov6t_iFOG1XxF72YEW--nzOzTlZ9pzCawpUvPkKtIRcSCbOKJwLqJjM6wfZMS1lmfNSfn-YHR-Qo-xJjDcAUArgj7OjArgEVrLj7M9Mhx84oCWuG4L2PQY9uDWSoK3zwyJd-w1ZY4irSH4vfItkHlDH4X-g8eF2bnRnMJCz2fTL5dUsn5IhON2evyW6Gz0wdMnAd7qdkD742KMZ_SZJr7N-6SLaCel8l7uuweB8cMOG9AsdkbCd1NPsUaPbiM_235Ps28cPs4tP-fXny6uL6XVuBMghb4Thdm4raaUVQnBqsAGj59RYXUrbpIlloracN1zPoagqkCVjnAuYcykYO8le7XTTmr9WGAeVtjPYtrpDv4qqLkRVj-neS0rG6nRYkciXd8gbv0qJtFEJqIu6KGmVIL6DTMonBmxUH9xSh42ioMby1bZ8NXqPo235qk7vXuzFV_Ml2sOr27YTcLoHdDS6bVLkxsV_HAOoZQmJe7_jMMW7dhhUNA5TrdaFVJey3t27yrs7CqZ1nUumP3GD8fDTVMVCwU5k1KCwVajZX0qd4rg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>609292418</pqid></control><display><type>article</type><title>Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><source>ProQuest Central UK/Ireland</source><creator>Vaidya, Jayant S, Dr ; Joseph, David J, MD ; Tobias, Jeffrey S, FRCR ; Bulsara, Max, PhD ; Wenz, Frederik, MD ; Saunders, Christobel, FRCS ; Alvarado, Michael, MD ; Flyger, Henrik L, MD ; Massarut, Samuele, MD ; Eiermann, Wolfgang, MD ; Keshtgar, Mohammed, PhD ; Dewar, John, FRCR ; Kraus-Tiefenbacher, Uta, MD ; Sütterlin, Marc, MD ; Esserman, Laura, MD ; Holtveg, Helle MR, MD ; Roncadin, Mario, MD ; Pigorsch, Steffi, MD ; Metaxas, Marinos, PhD ; Falzon, Mary, FRCPath ; Matthews, April, BSc ; Corica, Tammy, PGDPH ; Williams, Norman R, PhD ; Baum, Michael, FRCS</creator><creatorcontrib>Vaidya, Jayant S, Dr ; Joseph, David J, MD ; Tobias, Jeffrey S, FRCR ; Bulsara, Max, PhD ; Wenz, Frederik, MD ; Saunders, Christobel, FRCS ; Alvarado, Michael, MD ; Flyger, Henrik L, MD ; Massarut, Samuele, MD ; Eiermann, Wolfgang, MD ; Keshtgar, Mohammed, PhD ; Dewar, John, FRCR ; Kraus-Tiefenbacher, Uta, MD ; Sütterlin, Marc, MD ; Esserman, Laura, MD ; Holtveg, Helle MR, MD ; Roncadin, Mario, MD ; Pigorsch, Steffi, MD ; Metaxas, Marinos, PhD ; Falzon, Mary, FRCPath ; Matthews, April, BSc ; Corica, Tammy, PGDPH ; Williams, Norman R, PhD ; Baum, Michael, FRCS</creatorcontrib><description>Summary Background After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy. Methods Having safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam, we launched the TARGIT-A trial on March 24, 2000. In this prospective, randomised, non-inferiority trial, women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries. Patients were randomly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy. Neither patients nor investigators or their teams were masked to treatment assignment. Postoperative discovery of predefined factors (eg, lobular carcinoma) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy (in an expected 15% of patients). The primary outcome was local recurrence in the conserved breast. The predefined non-inferiority margin was an absolute difference of 2·5% in the primary endpoint. All randomised patients were included in the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov , number NCT00983684. Findings 1113 patients were randomly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy. Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group, 854 (86%) received targeted intraoperative radiotherapy only and 142 (14%) received targeted intraoperative radiotherapy plus external beam radiotherapy. 1025 (92%) patients in the external beam radiotherapy group received the allocated treatment. At 4 years, there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group. The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1·20% (95% CI 0·53–2·71) in the targeted intraoperative radiotherapy and 0·95% (0·39–2·31) in the external beam radiotherapy group (difference between groups 0·25%, −1·04 to 1·54; p=0·41). The frequency of any complications and major toxicity was similar in the two groups (for major toxicity, targeted intraoperative radiotherapy, 37 [3·3%] of 1113 vs external beam radiotherapy, 44 [3·9%] of 1119; p=0·44). Radiotherapy toxicity (Radiation Therapy Oncology Group grade 3) was lower in the targeted intraoperative radiotherapy group (six patients [0·5%]) than in the external beam radiotherapy group (23 patients [2·1%]; p=0·002). Interpretation For selected patients with early breast cancer, a single dose of radiotherapy delivered at the time of surgery by use of targeted intraoperative radiotherapy should be considered as an alternative to external beam radiotherapy delivered over several weeks. Funding University College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre, UCLH Charities, National Institute for Health Research Health Technology Assessment programme, Ninewells Cancer Campaign, National Health and Medical Research Council, and German Federal Ministry of Education and Research (BMBF).</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(10)60837-9</identifier><identifier>PMID: 20570343</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Aged ; Biological and medical sciences ; Breast cancer ; Breast carcinoma ; Breast Neoplasms - pathology ; Breast Neoplasms - radiotherapy ; Breast Neoplasms - surgery ; Cancer therapies ; Carcinoma, Ductal, Breast - pathology ; Carcinoma, Ductal, Breast - radiotherapy ; Carcinoma, Ductal, Breast - surgery ; Clinical trials ; Colleges & universities ; Disease-Free Survival ; Female ; General aspects ; Gynecology. Andrology. Obstetrics ; Hospitals ; Humans ; Internal Medicine ; Intraoperative Care ; Invasiveness ; Mammary gland diseases ; Mastectomy, Segmental ; Medical research ; Medical sciences ; Middle Aged ; Neoplasm Recurrence, Local ; Oncology ; Radiation ; Radiation therapy ; Radiotherapy ; Radiotherapy Dosage ; Radiotherapy, Adjuvant ; Surgery ; Technology assessment ; Toxicity ; Tumors</subject><ispartof>The Lancet (British edition), 2010-07, Vol.376 (9735), p.91-102</ispartof><rights>Elsevier Ltd</rights><rights>2010 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright 2010 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jul 10-Jul 16, 2010</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c607t-f6c5dbd87d7d66651cef0cab1cda47df651d369d55f5ab0288074335560b57633</citedby><cites>FETCH-LOGICAL-c607t-f6c5dbd87d7d66651cef0cab1cda47df651d369d55f5ab0288074335560b57633</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/609292418?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976,64364,64366,64368,72218</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23009740$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20570343$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vaidya, Jayant S, Dr</creatorcontrib><creatorcontrib>Joseph, David J, MD</creatorcontrib><creatorcontrib>Tobias, Jeffrey S, FRCR</creatorcontrib><creatorcontrib>Bulsara, Max, PhD</creatorcontrib><creatorcontrib>Wenz, Frederik, MD</creatorcontrib><creatorcontrib>Saunders, Christobel, FRCS</creatorcontrib><creatorcontrib>Alvarado, Michael, MD</creatorcontrib><creatorcontrib>Flyger, Henrik L, MD</creatorcontrib><creatorcontrib>Massarut, Samuele, MD</creatorcontrib><creatorcontrib>Eiermann, Wolfgang, MD</creatorcontrib><creatorcontrib>Keshtgar, Mohammed, PhD</creatorcontrib><creatorcontrib>Dewar, John, FRCR</creatorcontrib><creatorcontrib>Kraus-Tiefenbacher, Uta, MD</creatorcontrib><creatorcontrib>Sütterlin, Marc, MD</creatorcontrib><creatorcontrib>Esserman, Laura, MD</creatorcontrib><creatorcontrib>Holtveg, Helle MR, MD</creatorcontrib><creatorcontrib>Roncadin, Mario, MD</creatorcontrib><creatorcontrib>Pigorsch, Steffi, MD</creatorcontrib><creatorcontrib>Metaxas, Marinos, PhD</creatorcontrib><creatorcontrib>Falzon, Mary, FRCPath</creatorcontrib><creatorcontrib>Matthews, April, BSc</creatorcontrib><creatorcontrib>Corica, Tammy, PGDPH</creatorcontrib><creatorcontrib>Williams, Norman R, PhD</creatorcontrib><creatorcontrib>Baum, Michael, FRCS</creatorcontrib><title>Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Summary Background After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy. Methods Having safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam, we launched the TARGIT-A trial on March 24, 2000. In this prospective, randomised, non-inferiority trial, women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries. Patients were randomly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy. Neither patients nor investigators or their teams were masked to treatment assignment. Postoperative discovery of predefined factors (eg, lobular carcinoma) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy (in an expected 15% of patients). The primary outcome was local recurrence in the conserved breast. The predefined non-inferiority margin was an absolute difference of 2·5% in the primary endpoint. All randomised patients were included in the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov , number NCT00983684. Findings 1113 patients were randomly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy. Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group, 854 (86%) received targeted intraoperative radiotherapy only and 142 (14%) received targeted intraoperative radiotherapy plus external beam radiotherapy. 1025 (92%) patients in the external beam radiotherapy group received the allocated treatment. At 4 years, there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group. The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1·20% (95% CI 0·53–2·71) in the targeted intraoperative radiotherapy and 0·95% (0·39–2·31) in the external beam radiotherapy group (difference between groups 0·25%, −1·04 to 1·54; p=0·41). The frequency of any complications and major toxicity was similar in the two groups (for major toxicity, targeted intraoperative radiotherapy, 37 [3·3%] of 1113 vs external beam radiotherapy, 44 [3·9%] of 1119; p=0·44). Radiotherapy toxicity (Radiation Therapy Oncology Group grade 3) was lower in the targeted intraoperative radiotherapy group (six patients [0·5%]) than in the external beam radiotherapy group (23 patients [2·1%]; p=0·002). Interpretation For selected patients with early breast cancer, a single dose of radiotherapy delivered at the time of surgery by use of targeted intraoperative radiotherapy should be considered as an alternative to external beam radiotherapy delivered over several weeks. Funding University College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre, UCLH Charities, National Institute for Health Research Health Technology Assessment programme, Ninewells Cancer Campaign, National Health and Medical Research Council, and German Federal Ministry of Education and Research (BMBF).</description><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Breast cancer</subject><subject>Breast carcinoma</subject><subject>Breast Neoplasms - pathology</subject><subject>Breast Neoplasms - radiotherapy</subject><subject>Breast Neoplasms - surgery</subject><subject>Cancer therapies</subject><subject>Carcinoma, Ductal, Breast - pathology</subject><subject>Carcinoma, Ductal, Breast - radiotherapy</subject><subject>Carcinoma, Ductal, Breast - surgery</subject><subject>Clinical trials</subject><subject>Colleges & universities</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>General aspects</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Intraoperative Care</subject><subject>Invasiveness</subject><subject>Mammary gland diseases</subject><subject>Mastectomy, Segmental</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Recurrence, Local</subject><subject>Oncology</subject><subject>Radiation</subject><subject>Radiation therapy</subject><subject>Radiotherapy</subject><subject>Radiotherapy Dosage</subject><subject>Radiotherapy, Adjuvant</subject><subject>Surgery</subject><subject>Technology assessment</subject><subject>Toxicity</subject><subject>Tumors</subject><issn>0140-6736</issn><issn>1474-547X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkVFv0zAUhSMEYmPwE0AW0sQmNXAdx3bCA6iaYEyahARF4s1y7RvqkcbBTov6t_iFOG1XxF72YEW--nzOzTlZ9pzCawpUvPkKtIRcSCbOKJwLqJjM6wfZMS1lmfNSfn-YHR-Qo-xJjDcAUArgj7OjArgEVrLj7M9Mhx84oCWuG4L2PQY9uDWSoK3zwyJd-w1ZY4irSH4vfItkHlDH4X-g8eF2bnRnMJCz2fTL5dUsn5IhON2evyW6Gz0wdMnAd7qdkD742KMZ_SZJr7N-6SLaCel8l7uuweB8cMOG9AsdkbCd1NPsUaPbiM_235Ps28cPs4tP-fXny6uL6XVuBMghb4Thdm4raaUVQnBqsAGj59RYXUrbpIlloracN1zPoagqkCVjnAuYcykYO8le7XTTmr9WGAeVtjPYtrpDv4qqLkRVj-neS0rG6nRYkciXd8gbv0qJtFEJqIu6KGmVIL6DTMonBmxUH9xSh42ioMby1bZ8NXqPo235qk7vXuzFV_Ml2sOr27YTcLoHdDS6bVLkxsV_HAOoZQmJe7_jMMW7dhhUNA5TrdaFVJey3t27yrs7CqZ1nUumP3GD8fDTVMVCwU5k1KCwVajZX0qd4rg</recordid><startdate>20100710</startdate><enddate>20100710</enddate><creator>Vaidya, Jayant S, Dr</creator><creator>Joseph, David J, MD</creator><creator>Tobias, Jeffrey S, FRCR</creator><creator>Bulsara, Max, PhD</creator><creator>Wenz, Frederik, MD</creator><creator>Saunders, Christobel, FRCS</creator><creator>Alvarado, Michael, MD</creator><creator>Flyger, Henrik L, MD</creator><creator>Massarut, Samuele, MD</creator><creator>Eiermann, Wolfgang, MD</creator><creator>Keshtgar, Mohammed, PhD</creator><creator>Dewar, John, FRCR</creator><creator>Kraus-Tiefenbacher, Uta, MD</creator><creator>Sütterlin, Marc, MD</creator><creator>Esserman, Laura, MD</creator><creator>Holtveg, Helle MR, MD</creator><creator>Roncadin, Mario, MD</creator><creator>Pigorsch, Steffi, MD</creator><creator>Metaxas, Marinos, PhD</creator><creator>Falzon, Mary, FRCPath</creator><creator>Matthews, April, BSc</creator><creator>Corica, Tammy, PGDPH</creator><creator>Williams, Norman R, PhD</creator><creator>Baum, Michael, FRCS</creator><general>Elsevier Ltd</general><general>Elsevier</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TT</scope><scope>0TZ</scope><scope>0U~</scope><scope>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88A</scope><scope>88C</scope><scope>88E</scope><scope>88G</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>KB~</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope></search><sort><creationdate>20100710</creationdate><title>Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial</title><author>Vaidya, Jayant S, Dr ; Joseph, David J, MD ; Tobias, Jeffrey S, FRCR ; Bulsara, Max, PhD ; Wenz, Frederik, MD ; Saunders, Christobel, FRCS ; Alvarado, Michael, MD ; Flyger, Henrik L, MD ; Massarut, Samuele, MD ; Eiermann, Wolfgang, MD ; Keshtgar, Mohammed, PhD ; Dewar, John, FRCR ; Kraus-Tiefenbacher, Uta, MD ; Sütterlin, Marc, MD ; Esserman, Laura, MD ; Holtveg, Helle MR, MD ; Roncadin, Mario, MD ; Pigorsch, Steffi, MD ; Metaxas, Marinos, PhD ; Falzon, Mary, FRCPath ; Matthews, April, BSc ; Corica, Tammy, PGDPH ; Williams, Norman R, PhD ; Baum, Michael, FRCS</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c607t-f6c5dbd87d7d66651cef0cab1cda47df651d369d55f5ab0288074335560b57633</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Breast cancer</topic><topic>Breast carcinoma</topic><topic>Breast Neoplasms - pathology</topic><topic>Breast Neoplasms - radiotherapy</topic><topic>Breast Neoplasms - surgery</topic><topic>Cancer therapies</topic><topic>Carcinoma, Ductal, Breast - pathology</topic><topic>Carcinoma, Ductal, Breast - radiotherapy</topic><topic>Carcinoma, Ductal, Breast - surgery</topic><topic>Clinical trials</topic><topic>Colleges & universities</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>General aspects</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Intraoperative Care</topic><topic>Invasiveness</topic><topic>Mammary gland diseases</topic><topic>Mastectomy, Segmental</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasm Recurrence, Local</topic><topic>Oncology</topic><topic>Radiation</topic><topic>Radiation therapy</topic><topic>Radiotherapy</topic><topic>Radiotherapy Dosage</topic><topic>Radiotherapy, Adjuvant</topic><topic>Surgery</topic><topic>Technology assessment</topic><topic>Toxicity</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vaidya, Jayant S, Dr</creatorcontrib><creatorcontrib>Joseph, David J, MD</creatorcontrib><creatorcontrib>Tobias, Jeffrey S, FRCR</creatorcontrib><creatorcontrib>Bulsara, Max, PhD</creatorcontrib><creatorcontrib>Wenz, Frederik, MD</creatorcontrib><creatorcontrib>Saunders, Christobel, FRCS</creatorcontrib><creatorcontrib>Alvarado, Michael, MD</creatorcontrib><creatorcontrib>Flyger, Henrik L, MD</creatorcontrib><creatorcontrib>Massarut, Samuele, MD</creatorcontrib><creatorcontrib>Eiermann, Wolfgang, MD</creatorcontrib><creatorcontrib>Keshtgar, Mohammed, PhD</creatorcontrib><creatorcontrib>Dewar, John, FRCR</creatorcontrib><creatorcontrib>Kraus-Tiefenbacher, Uta, MD</creatorcontrib><creatorcontrib>Sütterlin, Marc, MD</creatorcontrib><creatorcontrib>Esserman, Laura, MD</creatorcontrib><creatorcontrib>Holtveg, Helle MR, MD</creatorcontrib><creatorcontrib>Roncadin, Mario, MD</creatorcontrib><creatorcontrib>Pigorsch, Steffi, MD</creatorcontrib><creatorcontrib>Metaxas, Marinos, PhD</creatorcontrib><creatorcontrib>Falzon, Mary, FRCPath</creatorcontrib><creatorcontrib>Matthews, April, BSc</creatorcontrib><creatorcontrib>Corica, Tammy, PGDPH</creatorcontrib><creatorcontrib>Williams, Norman R, PhD</creatorcontrib><creatorcontrib>Baum, Michael, FRCS</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>News PRO</collection><collection>Pharma and Biotech Premium PRO</collection><collection>Global News & ABI/Inform Professional</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Biology Database (Alumni Edition)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Lancet Titles</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>British Nursing Index</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>British Nursing Index</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Newsstand Professional</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vaidya, Jayant S, Dr</au><au>Joseph, David J, MD</au><au>Tobias, Jeffrey S, FRCR</au><au>Bulsara, Max, PhD</au><au>Wenz, Frederik, MD</au><au>Saunders, Christobel, FRCS</au><au>Alvarado, Michael, MD</au><au>Flyger, Henrik L, MD</au><au>Massarut, Samuele, MD</au><au>Eiermann, Wolfgang, MD</au><au>Keshtgar, Mohammed, PhD</au><au>Dewar, John, FRCR</au><au>Kraus-Tiefenbacher, Uta, MD</au><au>Sütterlin, Marc, MD</au><au>Esserman, Laura, MD</au><au>Holtveg, Helle MR, MD</au><au>Roncadin, Mario, MD</au><au>Pigorsch, Steffi, MD</au><au>Metaxas, Marinos, PhD</au><au>Falzon, Mary, FRCPath</au><au>Matthews, April, BSc</au><au>Corica, Tammy, PGDPH</au><au>Williams, Norman R, PhD</au><au>Baum, Michael, FRCS</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2010-07-10</date><risdate>2010</risdate><volume>376</volume><issue>9735</issue><spage>91</spage><epage>102</epage><pages>91-102</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary Background After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy. Methods Having safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam, we launched the TARGIT-A trial on March 24, 2000. In this prospective, randomised, non-inferiority trial, women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries. Patients were randomly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy. Neither patients nor investigators or their teams were masked to treatment assignment. Postoperative discovery of predefined factors (eg, lobular carcinoma) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy (in an expected 15% of patients). The primary outcome was local recurrence in the conserved breast. The predefined non-inferiority margin was an absolute difference of 2·5% in the primary endpoint. All randomised patients were included in the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov , number NCT00983684. Findings 1113 patients were randomly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy. Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group, 854 (86%) received targeted intraoperative radiotherapy only and 142 (14%) received targeted intraoperative radiotherapy plus external beam radiotherapy. 1025 (92%) patients in the external beam radiotherapy group received the allocated treatment. At 4 years, there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group. The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1·20% (95% CI 0·53–2·71) in the targeted intraoperative radiotherapy and 0·95% (0·39–2·31) in the external beam radiotherapy group (difference between groups 0·25%, −1·04 to 1·54; p=0·41). The frequency of any complications and major toxicity was similar in the two groups (for major toxicity, targeted intraoperative radiotherapy, 37 [3·3%] of 1113 vs external beam radiotherapy, 44 [3·9%] of 1119; p=0·44). Radiotherapy toxicity (Radiation Therapy Oncology Group grade 3) was lower in the targeted intraoperative radiotherapy group (six patients [0·5%]) than in the external beam radiotherapy group (23 patients [2·1%]; p=0·002). Interpretation For selected patients with early breast cancer, a single dose of radiotherapy delivered at the time of surgery by use of targeted intraoperative radiotherapy should be considered as an alternative to external beam radiotherapy delivered over several weeks. Funding University College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre, UCLH Charities, National Institute for Health Research Health Technology Assessment programme, Ninewells Cancer Campaign, National Health and Medical Research Council, and German Federal Ministry of Education and Research (BMBF).</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>20570343</pmid><doi>10.1016/S0140-6736(10)60837-9</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0140-6736 |
ispartof | The Lancet (British edition), 2010-07, Vol.376 (9735), p.91-102 |
issn | 0140-6736 1474-547X |
language | eng |
recordid | cdi_proquest_miscellaneous_926896736 |
source | MEDLINE; Elsevier ScienceDirect Journals; ProQuest Central UK/Ireland |
subjects | Aged Biological and medical sciences Breast cancer Breast carcinoma Breast Neoplasms - pathology Breast Neoplasms - radiotherapy Breast Neoplasms - surgery Cancer therapies Carcinoma, Ductal, Breast - pathology Carcinoma, Ductal, Breast - radiotherapy Carcinoma, Ductal, Breast - surgery Clinical trials Colleges & universities Disease-Free Survival Female General aspects Gynecology. Andrology. Obstetrics Hospitals Humans Internal Medicine Intraoperative Care Invasiveness Mammary gland diseases Mastectomy, Segmental Medical research Medical sciences Middle Aged Neoplasm Recurrence, Local Oncology Radiation Radiation therapy Radiotherapy Radiotherapy Dosage Radiotherapy, Adjuvant Surgery Technology assessment Toxicity Tumors |
title | Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-19T10%3A11%3A35IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Targeted%20intraoperative%20radiotherapy%20versus%20whole%20breast%20radiotherapy%20for%20breast%20cancer%20(TARGIT-A%20trial):%20an%20international,%20prospective,%20randomised,%20non-inferiority%20phase%203%20trial&rft.jtitle=The%20Lancet%20(British%20edition)&rft.au=Vaidya,%20Jayant%20S,%20Dr&rft.date=2010-07-10&rft.volume=376&rft.issue=9735&rft.spage=91&rft.epage=102&rft.pages=91-102&rft.issn=0140-6736&rft.eissn=1474-547X&rft.coden=LANCAO&rft_id=info:doi/10.1016/S0140-6736(10)60837-9&rft_dat=%3Cproquest_cross%3E2079967331%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=609292418&rft_id=info:pmid/20570343&rft_els_id=S0140673610608379&rfr_iscdi=true |